Senior Reliability/Quality Engineer

Position Description

The Senior Quality Engineer has frequent inter-organizational and outside customer and supplier contacts. The Senior QA Engineer II represents the organization in providing solutions to difficult technical issues associated with specific programs or projects. The Senior Quality Engineer has the responsibility and authority to provide Quality Assurance Engineering representation to select business teams facilitating front-end design, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness.  Coordinate feedback of quality indicators and statistics to business team for use in business decisions.  Partner with Manufacturing Engineers in process improvements. Perform, direct, or consult in validations.  QA approvals for Engineering Change Notices, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards.  Drive investigations, corrective action implementation, and corrective action verification activities assigned to business teams. The Senior Quality Engineer works under only general direction and independently determines and develops approaches to problem resolution and product or process improvements. The Senior Quality Engineer’s work is reviewed upon completion for adequacy in meeting objectives. The Senior QA Engineer II contributes to the completion of specific programs and projects. Failure to achieve results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure or resources.

Position Responsibilities

Participates in Business Team operations to approve testing of all new product designs, design test parameters for R&D, Operations and QA, conduct reliability assessments,  evaluates and approves ECN changes for existing products, monitor design developments for maintaining quality compliance and assists in software engineering, testing, and validation. Partners with Mfg. Engineering to assist in developing test methods, equipment acquisition for new product testing, validations/qualifications, statistical analysis of data for significance, and other documented requirements for quality objectives. Participates in new product development, and establish quality and reliability expectancy of the finished product. Identifies, applies, and updates engineering and technical standards requirements for devices, including standards compliance in product design, manufacture, and labeling. Investigates and reports on corrective actions effectiveness and timeliness.  Assists audits of finished products, final inspections, returned and serviced products. Minimal travel up to 20%. Performs other duties as assigned. Complies with the Medtronic Xomed Quality System.

Basic Qualifications

Minimum of five to eight years experience with a Bachelors degree in engineering or three to six years with a Masters degree in engineering.
Three to five years Quality Engineering experience. Experience in medical device design and application of test standards.  Minimum of five years industry experience, preferably in the medical device manufacturing industry.
Working knowledge of IEC606-1, UL2601-1, EMC Directive, and other appropriate industry standards. Experience in application of statistical methods to design reliability and process capability. Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired. If Bachelors or Masters degree is not in engineering an applicable professional certification is required.

Desired/Preferred Qualifications

Complete understanding and wide application of technical principles, theories, and concepts in the field.  General knowledge of other related disciplines. Ability to provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives. Good oral and written communication skills. Cross-functionally and an effective team player. Excellent presentation skills. Must be able to handle multiple tasks/projects and manage priorities accordingly. Working knowledge of appropriate industry standards. Experience in application statistical methods to design reliability and process capability. Must be able to work in a team environment and exert influence without alienating others. Working knowledge of statistical analysis/software experience preferred. Proficiency in Microsoft Project.

Physical Job Requirements

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and reach with hands and arms. The employee is regularly required to stand; walk and use hands to finger, handle, or feel. The employee must frequently lift and/or move up to 10 pounds.  Specific vision abilities required by this job include ability to adjust focus.